US6280462B1 - Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode - Google Patents

Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode Download PDF

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Publication number
US6280462B1
US6280462B1 US09/689,018 US68901800A US6280462B1 US 6280462 B1 US6280462 B1 US 6280462B1 US 68901800 A US68901800 A US 68901800A US 6280462 B1 US6280462 B1 US 6280462B1
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United States
Prior art keywords
pulse generator
shock
cardiac
generator housing
defibrillation electrode
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Expired - Fee Related
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US09/689,018
Inventor
Robert G. Hauser
Roger W. Dahl
Bruce H. Kenknight
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Cardiac Pacemakers Inc
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Cardiac Pacemakers Inc
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Filing date
Publication date
Priority claimed from US07/514,251 external-priority patent/US5133353A/en
Priority claimed from US07/917,899 external-priority patent/US5301503A/en
Application filed by Cardiac Pacemakers Inc filed Critical Cardiac Pacemakers Inc
Priority to US09/689,018 priority Critical patent/US6280462B1/en
Priority to US09/884,862 priority patent/US6999814B2/en
Application granted granted Critical
Publication of US6280462B1 publication Critical patent/US6280462B1/en
Priority to US11/026,707 priority patent/US7522959B2/en
Priority to US11/324,474 priority patent/US20060142804A1/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/362Heart stimulators
    • A61N1/365Heart stimulators controlled by a physiological parameter, e.g. heart potential
    • A61N1/368Heart stimulators controlled by a physiological parameter, e.g. heart potential comprising more than one electrode co-operating with different heart regions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/37512Pacemakers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/36Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
    • A61N1/372Arrangements in connection with the implantation of stimulators
    • A61N1/375Constructional arrangements, e.g. casings
    • A61N1/3756Casings with electrodes thereon, e.g. leadless stimulators

Definitions

  • This invention relates to an implantable cardiac stimulation lead and electrode system for applying electrical energy to an abnormally functioning heart and more particularly to an implantable pulse generator housing having electrically conductive walls serving as a defibrillation discharge electrode.
  • Electrodes implanted in the body for electrical stimulation of muscle or body organs are well known. More specifically, electrodes implanted on or about the heart have been used to reverse certain abnormal and life-threatening arrhythmias. Electrical energy is applied to the heart via the electrodes to return the heart to normal sinus rhythm.
  • bradycardia slower than normal heartbeat rhythm
  • ventricular tachycardia faster than normal heartbeat rhythm
  • ventricular fibrillation sporadic and uncoordinated beating of the heart. The latter two arrhythmias generally are fatal if left untreated.
  • a multiple electrode unitary intravascular cardiac catheter having a distal electrode for sensing and pacing, an intermediate electrode for sensing, pacing and cardioverting, and a proximal electrode for sensing and cardioverting. This multiple electrode catheter maintains the ability for heart rate sensing and low threshold pacing immediately following cardioversion.
  • U.S. Pat. No. 4,825,871 to Cansell discloses a defibrillation/cardioversion shock system in which the box housing the pulse generator circuitry serves as a support for a discharge electrode. Specifically, the metal box is enclosed by a plastics material and a metal plate is attached to the metal box and electrically connected therewith. Charges collected by the metal plate are transmitted to the metal box, which serves as a collector. The metal box itself is not used as an electrode in the Cansell system.
  • implantable cardiac stimulation lead system capable of performing standard pacing, such as anti-bradycardia pacing, anti-tachycardia pacing, low-energy cardioversion, and high-energy defibrillation.
  • the implantable cardiac stimulation lead system of the present invention comprises a transvenous endocardial or epicardial lead having a plurality of electrodes.
  • the lead electrodes are capable of sensing and performing standard anti-bradycardia pacing, anti-tachycardia pacing, cardioversion and defibrillation.
  • the transvenous lead is connected to a pulse generator having full-function pacing capabilities as well as cardioversion and defibrillation capabilities.
  • the housing of the pulse generator (together with, as desired, electrical discharge surfaces extending therefrom) is conductive and is connected to the pulse generator circuitry so that it may selectively serve as a discharge electrode.
  • the outer surface of the pulse generator could be of a special configuration to facilitate its discharge capabilities.
  • the pulse generator is implanted in the pectoral or abdominal region of the body proximate the heart.
  • a programmable switch or other type of circuitry is provided to select the electrode configuration which may include or exclude the pulse generator housing electrode.
  • the electrode surface of the pulse generator housing comprises a portion of the conductive wall of the housing.
  • the electrode surface comprises conductive mesh attached to the pulse generator housing.
  • the pulse generator housing is a metal housing, all or selective ones of the surfaces of which, together with, as desired, electrical discharge surfaces extending therefrom, are conductive.
  • the other surface of the conductive pulse generator housing is platinum.
  • the fifth embodiment relates to dedicating isolated conductive surface regions from one another, such isolated regions may serve for separately sensing, pacing and shocking.
  • an insulative mask is disposed over a conductive surface of the pulse generator housing.
  • a sensing switch is used to determine when the pulse generator is implanted and when it is outside the body of the patient.
  • FIG. 1 is a perspective view illustrating the pulse generator housing serving as a cardiac electrode in accordance with a first embodiment of the present invention.
  • FIG. 2 is a cross-sectional view taken through line 2 — 2 of FIG. 1 .
  • FIG. 3 is a perspective view illustrating the pulse generator housing having conductive mesh on a face thereof for serving as a cardiac electrode in accordance with the second embodiment of the present invention.
  • FIG. 4 is a cross-sectional view taken through line 4 — 4 of FIG. 3 .
  • FIG. 5 is a side view of a transvenous electrode and lead used in conjunction with the pulse generator illustrated in FIG. 1 or FIG. 3 .
  • FIG. 6 is a diagram illustrating the placement of the pulse generator housing adjacent the heart and connected to the implanted transvenous electrode and lead.
  • FIG. 7 is a cross-sectional view of the pulse generator housing according to a third embodiment of the present invention.
  • FIG. 8 is a perspective view of the pulse generator housing according to a fourth embodiment.
  • FIG. 9 is a cross-sectional view taken through line 9 — 9 is of FIG. 8 .
  • FIG. 10 is a cross-sectional view of a portion of the pulse generators housing illustrating a fifth embodiment.
  • FIG. 11 is a perspective view of the pulse generator housing according to a sixth embodiment.
  • FIG. 12 is a perspective view of the pulse generator housing with extending discharge surfaces according to a seventh embodiment.
  • FIG. 13 is a perspective view of the pulse generator housing with extending discharge surfaces according to an eighth embodiment.
  • FIG. 14 is a perspective view of the pulse generator housing with extending discharge surfaces according to a ninth embodiment.
  • FIG. 15 is a front view of a patient illustrating a discharge configuration including the pulse generator according to the seventh embodiment.
  • FIG. 16 is a block diagram illustrating the pulse generator.
  • FIG. 17 is a block diagram showing the programmable switch.
  • housing 10 is of a rectangular box shape having four side walls, a top wall, and a bottom wall. In one embodiment, at least one of the side walls is highly conductive. To this end, housing 10 includes side wall 12 having an outer discharge surface 14 formed of highly electrically conductive material. The conductive surface 14 is connected to the pulse generator circuitry 18 via a programmable switch 16 . The pulse generator circuitry 18 is insulated from the outer discharge surface and electrically connected to electrode lead plug receptacle assembly 20 .
  • the number of side walls of housing 10 having conductive discharged surfaces may vary. However, it is envisioned that as many as (or more than) four side walls may be made electrically conductive.
  • a pulse generator housing of a second embodiment is illustrated at 10 ′.
  • Housing 10 ′ is similar to housing 10 of FIGS. 1 and 2 except the side wall 12 ′ includes a conductive mesh surface 14 ′.
  • the term “mesh” includes that as illustrated as well as any other high surface area conductive materials including microtextured materials.
  • conductive mesh surface 14 ′ is electrically connected via switch 16 to pulse generator circuitry 18 contained within housing 10 ′.
  • a separate conductive patch (not shown) could be added and connected to the bottom of the pulse generator housing to increase the conductive surface area. This patch could attach by a snap or other similar means to the housing.
  • the removable pulse generator patch electrode may take several forms.
  • One form may be a subcutaneous array comprised of a helical coil which encircles the pulse generator housing, and plugs into a terminal or the housing.
  • Another form may be an array of parallel or radiating conductive fingers which are funneled subcutaneously proximate the pulse generator housing.
  • a clamp may be provided to connect the patch electrode to the pulse generator housing.
  • additional electrical discharge surfaces may be connected to the pulse generator housing 10 .
  • a plurality of coiled segment electrodes 14 a tunnelled subcutaneously in the patient, may be connected so as to protrude from and form a contiguous electrical discharge surface with the pulse generator housing 10 .
  • This additional discharge surface area increases the efficiency of the combined coil segments/housing electrode by decreasing the impedance and increasing the effective electrode surface area.
  • This combination has particular application to counter-shock treatment of tachy-arrhythmias.
  • FIG. 13 An alternative embodiment is illustrated in FIG. 13, in which a coiled loop 14 b connected to a header 15 and disposed outside the SQ pocket serves as the additional discharge surface area.
  • FIG. 13 An alternative embodiment is illustrated in which a coiled loop 14 b connected to a header 15 and disposed outside the SQ pocket serves as the additional discharge surface area.
  • a membrane 14 b e.g. a silicone rubber layer, is attached to the side of housing 10 .
  • Coiled segment electrodes 14 a are joined to and protrude from membrane 14 b, membrane 14 b both supporting and providing structural orientation for coiled segment electrodes 14 a.
  • Lead 14 c electrically connects all electrodes 14 a, and is electrically connected via plug 14 d to the plug receptacle of pulse generator 10 .
  • FIG. 15 shows a discharge configuration now possible through use of an electrically conductive pulse generator housing of the present invention.
  • the pulse generator housing 10 is implanted so as to function as a pectoral electrode (position C).
  • Discharge paths are possible from an electrode at position RV to electrodes at positions SVC and C, as well as from electrodes at RV and SVC to electrodes at C and SQ.
  • this configuration may be used to terminate atrial arrhythmias with shocks given from SVC to C (or, alternatively, from SVC to SQ, or to C and SQ).
  • a pectoral electrode (housing 10 ) at C may be used for effecting atrial defibrillation by using a discharge path between an active electrode at RA and the housing 10 at position C.
  • the plug receptacle assembly 20 comprises a positive port 22 a and a negative port 22 b. This allows connection of implanted electrodes to the pulse generator circuitry, so that one electrode may serve as anode and one electrode may serve as a cathode. If desired, either electrode could be used in combination with the electrically conductive housing.
  • a sensor 19 is provided to determine whether the housing is outside the body of a patient or inside the body.
  • the purpose of the sensor 19 is to prevent a shock from be delivered while the housing is outside the body and perhaps held in the hand of a physician prior to implant.
  • the sensor 19 may be a thermal sensor to detect when the housing is at body temperature, indicative of being inside the body.
  • the sensor 19 controls the switch 16 to permit shocking via the pulse generator housing. When the temperature is other than body temperature, the sensor 19 controls the switch 16 so as to prevent discharge via the pulse generator housing by prohibiting connection to the pulse generator circuitry.
  • the senor may be embodied as a signal detector to detect some signal for a period of time before shocking. As a result, a shock may not be delivered when the unit is outside the body and not sensing signals from the body.
  • Pulse generator circuitry 18 has full-function pacing capabilities including pacing for bradycardia and tachycardia both to inhibit an intrinsic beat or to adapt the rate to a higher or lower rate.
  • circuitry 18 has cardioversion and defibrillation capabilities and includes cardiac detection circuitry capable of distinguishing when the heart is in normal sinus rhythm, should be paced, or requires higher energy cardioversion, or defibrillation.
  • the switch 16 is selectively activated to include or exclude the conductive surface(s) of the pulse generator housing 10 during the discharge sequence.
  • Pulse generator housing 10 or 10 ′ is typically used in conjunction with other cardiac electrodes implanted on or about a human heart.
  • One such lead is illustrated in FIG. 5 .
  • Lead 30 is provided having a catheter portion 31 supporting electrode 28 on the distal end as well as electrode 29 on a proximate end of catheter portion 31 .
  • Lead 30 includes plug connectors 32 - 34 at its proximal end.
  • a sensing tip electrode 36 may be provided at the distal tip of catheter portion 31 for sensing cardiac activity. Electrodes 28 and 29 could also have sensing capabilities.
  • lead 30 is implanted transvenously in the human heart 38 with electrode 28 in the right ventricle 40 and electrode 29 proximate the right atrium or the superior vena cava 42 .
  • a single catheter electrode may be used for placing the electrode in the right ventricle.
  • Pulse generator housing 10 or 10 ′ is implanted in the pectoral region proximate but not in contact with the heart, just under the skin.
  • the housing 10 or 10 ′ could be implanted in the abdominal region.
  • Plug connectors 32 - 34 are inserted into the appropriate ports 22 a, 22 b or 22 c (not shown) of the receptacle assembly 20 .
  • the electrode surface of the pulse generator housing may be used in a two electrode or three electrode configuration, and may replace one of the intravascular catheter electrodes.
  • the programmable switch 16 determines which electrodes are energized under control of circuitry 18 .
  • the switch is programmed so that it can select any combination of three electrodes, such as, for example, any combination of the right ventricular (RV) electrode 28 , pulse generator electrode surface 14 and superior vena cava (SVC) electrode 42 .
  • the superior vena cava electrode 42 may be replaced by a subcutaneous electrode.
  • the RV electrode is connected to terminal 22 a and the SVC or subcutaneous electrode is connected to terminal 22 b.
  • the pulse generator conductive surface would be electrically connected in common with the SVC or subcutaneous electrode.
  • the switch 16 may be programmed to discharge the RV electrode against the SVC (or subcutaneous) electrode and/or the pulse generator electrode surface(s).
  • the switch 16 is triggered so that the pulse generator circuitry 18 selects only electrode 28 to discharge to the pulse generator housing.
  • the switch 16 is triggered so that the pulse generator circuitry 18 selects both distal and proximal electrodes 28 and 29 , respectively, as well as the electrode discharge surface 14 to discharge energy from the conductive wall(s) of housing 10 or 10 ′ for delivering defibrillation electrical energy to the heart 38 .
  • a lower energy cardioverting shock can be applied between electrodes 28 and 29 against the conductive wall(s) of the pulse generator housing 10 or 10 ′. Thereafter, if the heart does not revert back to normal sinus rhythm, the higher energy defibrillation pulse is applied across the same electrodes.
  • the programmable switch 16 may be programmed to select one of the electrodes 28 and 29 , and the conductive electrode surface(s) of the pulse generator housing 10 or 10 ′. In this way, the electrode discharge surface 14 of the pulse generator housing 10 or 10 ′ will be discharged against only one of the electrodes 28 or 29 . Further, the choice between the electrodes 28 and 29 may be based on certain cardiac conditions.
  • FIG. 7 illustrates a pulse generator housing 50 according to a third embodiment.
  • the housing 50 is comprised of a titanium body 52 .
  • the internal pulse generator circuitry 18 and programmable switch 16 are connected to the body 52 as described in conjunction with FIG. 2 .
  • the entire outer surface of the body 52 may be conductive or selective surface portions may be made insulative.
  • an insulative ceramic material 70 may be sputtered (e.g. high energy plasma deposition) onto the conductive outer surface of the body 52 . This is useful to create a conductive surface which has a controlled current density, in much the same manner as recently developed defibrillation cardioversion patch electrodes. See, for example, commonly assigned U.S. Pat. No. 5,063,932.
  • the insulative material may take the form of a mask or in various patterns known to control current density across a conductive surface.
  • the insulative material may also take the form of silicone rubber.
  • FIG. 10 illustrates a modification to the embodiment of FIG. 7 in which the outer surfaces of the body 52 of the pulse generator housing 50 are coated with platinum 54 , a metal which does not anodize, thus maintaining performance of the housing walls 52 as an anode.
  • the platinum surface may be created by sputtering or high energy plasma deposition and further may be made a microporous surface to minimize kinetic losses (reduce interface impedance).
  • FIG. 11 illustrates a sixth embodiment in which regions of the conductive surface of the pulse generator housing are dedicated for certain functions.
  • the pulse generator housing 60 comprises electrically isolated conductive regions 62 , 64 and 66 . One or two of these regions may be dedicated for sensing purposes while others may be dedicated for shocking purposes. Each of these regions is connected to the pulse generator circuitry 18 .
  • a small isolated conductive surface 80 may be created by sputtering a small region of insulative material onto the body 52 .
  • a small region of conductive material such as platinum may be deposited onto the region 80 .
  • the region 82 is electrically connected to the pulse generator circuitry through the body 52 .
  • Such a small conductive regional may serve as a return (ground) for a pacing configuration, sensing configuration, etc.
  • pulse generator circuitry 18 has full-function pacing capabilities (pacer 80 ) including pacing for bradycardia and tachycardia both to inhibit an intrinsic beat or to adapt the rate to a higher or lower rate.
  • circuitry 18 has cardioversion and defibrillation capabilities (cardioverter/defibrillator 82 ) and includes cardiac detection circuitry 84 capable of distinguishing when the heart is in normal sinus rhythm, should be paced, or requires higher energy cardioversion, or even higher energy defibrillation.
  • the switch 16 is selectively activated to include or exclude the conductive surface of side wall 12 from the discharge sequence.

Abstract

A pulse generator housing for enclosing and containing pulse generator defibrillation circuitry. The housing is formed entirely of electrically conductive metal defining an electrically conductive outer surface which is connected to the pulse generator circuitry for delivering defibrillating energy to the heart. The pulse generator housing is implanted in the pectoral region proximate the heart with the conductive surface facing the heart. Regions of the conductive outer surface may be electrically isolated and dedicated for separately sensing and shocking. The outer surface may be coated with platinum. Additional coiled segment electrodes may extend from the housing and be electrically connected to the conductive outer surface so as to increase the effective conductive surface area. A sensor is provided to determine whether the housing is inside or outside a body of a patient to disconnect the pulse generator housing conductive surface from the pulse generator circuitry when the unit is outside the body of a patient.

Description

CROSS REFERENCE TO RELATED APPLICATIONS
This application is a continuation of U.S. patent application Ser. No. 09/344,843, now U.S. Pat. No. 6,157,860 filed on Jun. 28, 1999, which is a continuation of U.S. patent application Ser. No. 08/964,120, filed Nov. 4, 1997, now U.S. Pat. No. 5,916,238, which is a continuation of U.S. patent application Ser. No. 08/380,538, filed on Jan. 30, 1995, now U.S. Pat. No. 5,713,926, which is a continuation of U.S. patent application Ser. No. 07/917,899, filed Jul. 24, 1992, now U.S. Pat. No. 5,385,574, which is a continuation-in-part of U.S. patent application Ser. No. 07/514,251, filed on Apr. 25, 1990, now U.S. Pat. No. 5,133,353, the specifications of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION
This invention relates to an implantable cardiac stimulation lead and electrode system for applying electrical energy to an abnormally functioning heart and more particularly to an implantable pulse generator housing having electrically conductive walls serving as a defibrillation discharge electrode.
Electrodes implanted in the body for electrical stimulation of muscle or body organs are well known. More specifically, electrodes implanted on or about the heart have been used to reverse certain abnormal and life-threatening arrhythmias. Electrical energy is applied to the heart via the electrodes to return the heart to normal sinus rhythm.
Common abnormal cardiac arrhythmias include bradycardia (slower than normal heartbeat rhythm), ventricular tachycardia (faster than normal heartbeat rhythm), and ventricular fibrillation (sporadic and uncoordinated beating of the heart). The latter two arrhythmias generally are fatal if left untreated.
To control the heartbeat rhythm and prevent fatalities from ventricular tachycardia and fibrillation, several devices have been designed having the ability to stimulate the heart according to a sensed cardiac signal such as a sensed ECG signal. See for example U.S. Pat. No. 4,603,705 to Speicher et al. The Speicher et al. patent discloses a multiple electrode unitary intravascular cardiac catheter having a distal electrode for sensing and pacing, an intermediate electrode for sensing, pacing and cardioverting, and a proximal electrode for sensing and cardioverting. This multiple electrode catheter maintains the ability for heart rate sensing and low threshold pacing immediately following cardioversion.
There are many types of defibrillation cardioversion electrodes in the art. U.S. Pat. No. 4,825,871 to Cansell discloses a defibrillation/cardioversion shock system in which the box housing the pulse generator circuitry serves as a support for a discharge electrode. Specifically, the metal box is enclosed by a plastics material and a metal plate is attached to the metal box and electrically connected therewith. Charges collected by the metal plate are transmitted to the metal box, which serves as a collector. The metal box itself is not used as an electrode in the Cansell system.
The need therefore exists for implantable cardiac stimulation lead system capable of performing standard pacing, such as anti-bradycardia pacing, anti-tachycardia pacing, low-energy cardioversion, and high-energy defibrillation.
SUMMARY OF THE INVENTION
It is a primary object of this invention to provide an implantable cardiac stimulation lead system having pacemaking, cardioversion and higher energy defibrillation capabilities.
It is an additional object of this invention to provide an implantable cardiac stimulation lead system having pacemaking, cardioversion and defibrillation capabilities via a selectable defibrillation electrode configuration.
It is yet a further object of this invention to provide an implantable cardiac stimulation lead system utilizing a relatively small number of implantable parts.
It is still another object of the present invention to provide an implantable pulse generator housing made entirely or partially but in a selective manner, of electrically conductive material, serving as a defibrillation electrode.
It is yet a further object of the invention to provide an electrically conductive portion of an implantable pulse generator housing which, together with electrical discharge surfaces extending therefrom, serve as an electrode.
It is still another object of the present invention to reduce the size of the pulse generator housing by eliminating one terminal on the housing.
Briefly, the implantable cardiac stimulation lead system of the present invention comprises a transvenous endocardial or epicardial lead having a plurality of electrodes. Typically, the lead electrodes are capable of sensing and performing standard anti-bradycardia pacing, anti-tachycardia pacing, cardioversion and defibrillation. The transvenous lead is connected to a pulse generator having full-function pacing capabilities as well as cardioversion and defibrillation capabilities. The housing of the pulse generator (together with, as desired, electrical discharge surfaces extending therefrom) is conductive and is connected to the pulse generator circuitry so that it may selectively serve as a discharge electrode. The outer surface of the pulse generator could be of a special configuration to facilitate its discharge capabilities. Typically, the pulse generator is implanted in the pectoral or abdominal region of the body proximate the heart. A programmable switch or other type of circuitry is provided to select the electrode configuration which may include or exclude the pulse generator housing electrode. As a result, different electrode configurations can be obtained for specific types of cardiac stimulations.
In a first embodiment, the electrode surface of the pulse generator housing comprises a portion of the conductive wall of the housing.
In a second embodiment, the electrode surface comprises conductive mesh attached to the pulse generator housing.
In a third embodiment, the pulse generator housing is a metal housing, all or selective ones of the surfaces of which, together with, as desired, electrical discharge surfaces extending therefrom, are conductive.
In accordance with a fourth embodiment, the other surface of the conductive pulse generator housing is platinum.
The fifth embodiment relates to dedicating isolated conductive surface regions from one another, such isolated regions may serve for separately sensing, pacing and shocking.
In accordance with the sixth embodiment, an insulative mask is disposed over a conductive surface of the pulse generator housing.
In a seventh embodiment, a sensing switch is used to determine when the pulse generator is implanted and when it is outside the body of the patient.
The above objects and advantages of the present invention can be further understood when reference is made to the following description, taken in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view illustrating the pulse generator housing serving as a cardiac electrode in accordance with a first embodiment of the present invention.
FIG. 2 is a cross-sectional view taken through line 22 of FIG. 1.
FIG. 3 is a perspective view illustrating the pulse generator housing having conductive mesh on a face thereof for serving as a cardiac electrode in accordance with the second embodiment of the present invention.
FIG. 4 is a cross-sectional view taken through line 44 of FIG. 3.
FIG. 5 is a side view of a transvenous electrode and lead used in conjunction with the pulse generator illustrated in FIG. 1 or FIG. 3.
FIG. 6 is a diagram illustrating the placement of the pulse generator housing adjacent the heart and connected to the implanted transvenous electrode and lead.
FIG. 7 is a cross-sectional view of the pulse generator housing according to a third embodiment of the present invention.
FIG. 8 is a perspective view of the pulse generator housing according to a fourth embodiment.
FIG. 9 is a cross-sectional view taken through line 99 is of FIG. 8.
FIG. 10 is a cross-sectional view of a portion of the pulse generators housing illustrating a fifth embodiment.
FIG. 11 is a perspective view of the pulse generator housing according to a sixth embodiment.
FIG. 12 is a perspective view of the pulse generator housing with extending discharge surfaces according to a seventh embodiment.
FIG. 13 is a perspective view of the pulse generator housing with extending discharge surfaces according to an eighth embodiment.
FIG. 14 is a perspective view of the pulse generator housing with extending discharge surfaces according to a ninth embodiment.
FIG. 15 is a front view of a patient illustrating a discharge configuration including the pulse generator according to the seventh embodiment.
FIG. 16 is a block diagram illustrating the pulse generator.
FIG. 17 is a block diagram showing the programmable switch.
DETAILED DESCRIPTION OF THE DRAWINGS
Referring to FIGS. 1 and 2, the pulse generator housing of the present invention is generally shown at 10. Typically, housing 10 is of a rectangular box shape having four side walls, a top wall, and a bottom wall. In one embodiment, at least one of the side walls is highly conductive. To this end, housing 10 includes side wall 12 having an outer discharge surface 14 formed of highly electrically conductive material. The conductive surface 14 is connected to the pulse generator circuitry 18 via a programmable switch 16. The pulse generator circuitry 18 is insulated from the outer discharge surface and electrically connected to electrode lead plug receptacle assembly 20.
As previously mentioned, the number of side walls of housing 10 having conductive discharged surfaces may vary. However, it is envisioned that as many as (or more than) four side walls may be made electrically conductive.
Referring now to FIGS. 3 and 4, a pulse generator housing of a second embodiment is illustrated at 10′. Housing 10′ is similar to housing 10 of FIGS. 1 and 2 except the side wall 12′ includes a conductive mesh surface 14′. It is to be understood that, hereinafter, the term “mesh” includes that as illustrated as well as any other high surface area conductive materials including microtextured materials. As shown in FIG. 4, conductive mesh surface 14′ is electrically connected via switch 16 to pulse generator circuitry 18 contained within housing 10′. In addition a separate conductive patch (not shown) could be added and connected to the bottom of the pulse generator housing to increase the conductive surface area. This patch could attach by a snap or other similar means to the housing.
The removable pulse generator patch electrode may take several forms. One form may be a subcutaneous array comprised of a helical coil which encircles the pulse generator housing, and plugs into a terminal or the housing. Another form may be an array of parallel or radiating conductive fingers which are funneled subcutaneously proximate the pulse generator housing. A clamp may be provided to connect the patch electrode to the pulse generator housing.
In another embodiment, additional electrical discharge surfaces may be connected to the pulse generator housing 10. Thus, as illustrated in FIG. 12, a plurality of coiled segment electrodes 14 a, tunnelled subcutaneously in the patient, may be connected so as to protrude from and form a contiguous electrical discharge surface with the pulse generator housing 10. This additional discharge surface area increases the efficiency of the combined coil segments/housing electrode by decreasing the impedance and increasing the effective electrode surface area. This combination has particular application to counter-shock treatment of tachy-arrhythmias. An alternative embodiment is illustrated in FIG. 13, in which a coiled loop 14 b connected to a header 15 and disposed outside the SQ pocket serves as the additional discharge surface area. In yet another embodiment, illustrated in FIG. 14, a membrane 14 b, e.g. a silicone rubber layer, is attached to the side of housing 10. Coiled segment electrodes 14 a are joined to and protrude from membrane 14 b, membrane 14 b both supporting and providing structural orientation for coiled segment electrodes 14 a. Lead 14 c electrically connects all electrodes 14 a, and is electrically connected via plug 14 d to the plug receptacle of pulse generator 10.
FIG. 15 shows a discharge configuration now possible through use of an electrically conductive pulse generator housing of the present invention. In this configuration the pulse generator housing 10 is implanted so as to function as a pectoral electrode (position C). Discharge paths are possible from an electrode at position RV to electrodes at positions SVC and C, as well as from electrodes at RV and SVC to electrodes at C and SQ. Further, this configuration may be used to terminate atrial arrhythmias with shocks given from SVC to C (or, alternatively, from SVC to SQ, or to C and SQ). Similarly, a pectoral electrode (housing 10) at C may be used for effecting atrial defibrillation by using a discharge path between an active electrode at RA and the housing 10 at position C.
The plug receptacle assembly 20 comprises a positive port 22 a and a negative port 22 b. This allows connection of implanted electrodes to the pulse generator circuitry, so that one electrode may serve as anode and one electrode may serve as a cathode. If desired, either electrode could be used in combination with the electrically conductive housing.
A sensor 19 is provided to determine whether the housing is outside the body of a patient or inside the body. The purpose of the sensor 19 is to prevent a shock from be delivered while the housing is outside the body and perhaps held in the hand of a physician prior to implant. The sensor 19 may be a thermal sensor to detect when the housing is at body temperature, indicative of being inside the body. The sensor 19 controls the switch 16 to permit shocking via the pulse generator housing. When the temperature is other than body temperature, the sensor 19 controls the switch 16 so as to prevent discharge via the pulse generator housing by prohibiting connection to the pulse generator circuitry.
Alternatively, the sensor may be embodied as a signal detector to detect some signal for a period of time before shocking. As a result, a shock may not be delivered when the unit is outside the body and not sensing signals from the body.
Pulse generator circuitry 18 has full-function pacing capabilities including pacing for bradycardia and tachycardia both to inhibit an intrinsic beat or to adapt the rate to a higher or lower rate. In addition, circuitry 18 has cardioversion and defibrillation capabilities and includes cardiac detection circuitry capable of distinguishing when the heart is in normal sinus rhythm, should be paced, or requires higher energy cardioversion, or defibrillation. The switch 16 is selectively activated to include or exclude the conductive surface(s) of the pulse generator housing 10 during the discharge sequence.
Pulse generator housing 10 or 10′ is typically used in conjunction with other cardiac electrodes implanted on or about a human heart. One such lead is illustrated in FIG. 5. Lead 30 is provided having a catheter portion 31 supporting electrode 28 on the distal end as well as electrode 29 on a proximate end of catheter portion 31. Lead 30 includes plug connectors 32-34 at its proximal end. In addition, a sensing tip electrode 36 may be provided at the distal tip of catheter portion 31 for sensing cardiac activity. Electrodes 28 and 29 could also have sensing capabilities.
Referring to FIG. 6, in operation, lead 30 is implanted transvenously in the human heart 38 with electrode 28 in the right ventricle 40 and electrode 29 proximate the right atrium or the superior vena cava 42. Alternatively, a single catheter electrode may be used for placing the electrode in the right ventricle. Pulse generator housing 10 or 10′ is implanted in the pectoral region proximate but not in contact with the heart, just under the skin. Alternatively, the housing 10 or 10′ could be implanted in the abdominal region. Plug connectors 32-34 are inserted into the appropriate ports 22 a, 22 b or 22 c (not shown) of the receptacle assembly 20. In this implantation position, the electrode surface of the pulse generator housing may be used in a two electrode or three electrode configuration, and may replace one of the intravascular catheter electrodes.
Referring additionally to FIG. 17, when an arrhythmia is sensed where it is appropriate for an electrical pulse to be delivered to the heart 38, the programmable switch 16 determines which electrodes are energized under control of circuitry 18. The switch is programmed so that it can select any combination of three electrodes, such as, for example, any combination of the right ventricular (RV) electrode 28, pulse generator electrode surface 14 and superior vena cava (SVC) electrode 42. The superior vena cava electrode 42 may be replaced by a subcutaneous electrode. The RV electrode is connected to terminal 22 a and the SVC or subcutaneous electrode is connected to terminal 22 b. The pulse generator conductive surface would be electrically connected in common with the SVC or subcutaneous electrode. The switch 16 may be programmed to discharge the RV electrode against the SVC (or subcutaneous) electrode and/or the pulse generator electrode surface(s).
In another possible configuration, if the heart activity is slower or faster (bradycardia or tachycardia) than normal, the switch 16 is triggered so that the pulse generator circuitry 18 selects only electrode 28 to discharge to the pulse generator housing. On the other hand, if the sensed activity is indicative of rapid ventricular tachycardia or fibrillation requiring higher energy stimulation, the switch 16 is triggered so that the pulse generator circuitry 18 selects both distal and proximal electrodes 28 and 29, respectively, as well as the electrode discharge surface 14 to discharge energy from the conductive wall(s) of housing 10 or 10′ for delivering defibrillation electrical energy to the heart 38.
Also, prior to applying a high energy defibrillating shock to the heart, a lower energy cardioverting shock can be applied between electrodes 28 and 29 against the conductive wall(s) of the pulse generator housing 10 or 10′. Thereafter, if the heart does not revert back to normal sinus rhythm, the higher energy defibrillation pulse is applied across the same electrodes.
In yet another alternate form, the programmable switch 16 may be programmed to select one of the electrodes 28 and 29, and the conductive electrode surface(s) of the pulse generator housing 10 or 10′. In this way, the electrode discharge surface 14 of the pulse generator housing 10 or 10′ will be discharged against only one of the electrodes 28 or 29. Further, the choice between the electrodes 28 and 29 may be based on certain cardiac conditions.
FIG. 7 illustrates a pulse generator housing 50 according to a third embodiment. The housing 50 is comprised of a titanium body 52. The internal pulse generator circuitry 18 and programmable switch 16 are connected to the body 52 as described in conjunction with FIG. 2. The entire outer surface of the body 52 may be conductive or selective surface portions may be made insulative. Specifically, as shown in FIGS. 8 and 9, an insulative ceramic material 70 may be sputtered (e.g. high energy plasma deposition) onto the conductive outer surface of the body 52. This is useful to create a conductive surface which has a controlled current density, in much the same manner as recently developed defibrillation cardioversion patch electrodes. See, for example, commonly assigned U.S. Pat. No. 5,063,932. The insulative material may take the form of a mask or in various patterns known to control current density across a conductive surface. The insulative material may also take the form of silicone rubber.
FIG. 10 illustrates a modification to the embodiment of FIG. 7 in which the outer surfaces of the body 52 of the pulse generator housing 50 are coated with platinum 54, a metal which does not anodize, thus maintaining performance of the housing walls 52 as an anode. The platinum surface may be created by sputtering or high energy plasma deposition and further may be made a microporous surface to minimize kinetic losses (reduce interface impedance).
FIG. 11 illustrates a sixth embodiment in which regions of the conductive surface of the pulse generator housing are dedicated for certain functions. Specifically, the pulse generator housing 60 comprises electrically isolated conductive regions 62, 64 and 66. One or two of these regions may be dedicated for sensing purposes while others may be dedicated for shocking purposes. Each of these regions is connected to the pulse generator circuitry 18.
Additionally, a small isolated conductive surface 80 may be created by sputtering a small region of insulative material onto the body 52. A small region of conductive material such as platinum may be deposited onto the region 80. The region 82 is electrically connected to the pulse generator circuitry through the body 52.
Such a small conductive regional may serve as a return (ground) for a pacing configuration, sensing configuration, etc.
Referring to FIG. 16, pulse generator circuitry 18 has full-function pacing capabilities (pacer 80) including pacing for bradycardia and tachycardia both to inhibit an intrinsic beat or to adapt the rate to a higher or lower rate. In addition, circuitry 18 has cardioversion and defibrillation capabilities (cardioverter/defibrillator 82) and includes cardiac detection circuitry 84 capable of distinguishing when the heart is in normal sinus rhythm, should be paced, or requires higher energy cardioversion, or even higher energy defibrillation. The switch 16 is selectively activated to include or exclude the conductive surface of side wall 12 from the discharge sequence.
It is considered that the above description is intended by way of example only, and is not intended to limit the present invention in any way except as set forth in the following claims.

Claims (28)

We claim:
1. An implantable pulse generator, comprising:
multiple cardiac electrodes;
a pulse generator housing, where the pulse generator housing is electrically conductive;
pulse generator circuitry within the pulse generator housing, where the pulse generator circuitry senses cardiac signals with at least one of the multiple cardiac electrodes, detects at least a first cardiac condition and a second cardiac condition based upon one or more of the cardiac signals, and controls delivery of electrical energy through the pulse generator housing and at least one of the multiple cardiac electrodes; and
a switch coupled to the pulse generator circuitry, the multiple cardiac electrodes and the pulse generator housing, where the pulse generator circuitry controls the switch to apply a first shock having a first shock vector between the pulse generator housing and at least one of the multiple cardiac electrodes in response to the first cardiac condition and controls the switch to apply a second shock having a second shock vector, different than the first shock vector, between the pulse generator housing and at least one of the multiple cardiac electrodes in response to the second cardiac condition.
2. The implantable pulse generator of claim 1, wherein the pulse generator circuitry detects an atrial arrhythmia as the first cardiac condition and controls the switch to apply the first shock having the first shock vector in response to the atrial arrhythmia.
3. The implantable pulse generator of claim 2, wherein the pulse generator circuitry detects a ventricular arrhythmia as the second cardiac condition and controls the switch to apply the second shock having the second shock vector in response to the ventricular arrhythmia.
4. The implantable pulse generator of claim 3, wherein the multiple cardiac electrodes include a first defibrillation electrode adapted to be positioned in a supraventricular region, and where the first shock vector is between at least the first defibrillation electrode and the pulse generator housing.
5. The implantable pulse generator of claim 4, wherein the first defibrillation electrode is adapted to be positioned in or near an atrium of the supraventricular region.
6. The implantable pulse generator of claim 4, wherein the multiple cardiac electrodes include a second defibrillation electrode adapted to be positioned in a right ventricle, and where the second shock vector is at least between the second defibrillation electrode and the pulse generator housing.
7. The implantable pulse generator of claim 6, wherein the multiple cardiac electrodes include a third defibrillation electrode adapted to be positioned at least partially in a superior vena cava, and where the second shock vector is at least between the second defibrillation electrode, the third defibrillation electrode and the pulse generator housing, the third defibrillation electrode and the pulse generator housing being common.
8. The implantable pulse generator of claim 1, where the pulse generator circuitry is adapted to provide anti-arrhythmia pacemaking, cardioversion, and defibrillation capabilities for maintaining proper function of the heart.
9. A method, comprising:
sensing cardiac signals;
detecting a first cardiac condition from one or more of the cardiac signals;
applying a first shock in response to the first cardiac condition, the first shock having a first shock vector between a pulse generator housing and at least one of a multiple of electrodes;
detecting a second cardiac condition from one or more of the cardiac signals; and
applying a second shock in response to the second cardiac condition, the second shock having a second shock vector, different than the first shock vector, between the pulse generator housing and at least one of the multiple electrodes.
10. The method of claim 9, wherein detecting the first cardiac condition includes detecting an atrial arrhythmia.
11. The method of claim 10, wherein detecting the second cardiac condition includes detecting a ventricular arrhythmia.
12. The method of claim 11, where applying the first shock with the first vector includes applying the first shock between a first defibrillation electrode in a supraventricular region and the pulse generator housing.
13. The method of claim 12, wherein the supraventricular region is in or near an atrium.
14. The method of claim 12, where applying the second shock with the second vector includes applying the second shock between a second defibrillation electrode in a right ventricular region and the pulse generator housing.
15. The method of claim 14, where applying the second shock with the second vector includes applying the second shock between the second defibrillation electrode, the third defibrillation electrode at least partially in a superior vena cava and the pulse generator housing, where the third defibrillation electrode and the pulse generator housing are common.
16. An apparatus, comprising:
multiple cardiac electrodes;
an electrically conductive case;
control circuitry within the electrically conductive case, where the control circuitry receives cardiac signals sensed with at least one of the multiple cardiac electrodes, identifies at least a first arrhythmic condition and a second arrhythmic condition based upon one or more of the cardiac signals, and directs delivery of electrical energy through the electrically conductive case and at least one of the multiple cardiac electrodes, where the control circuitry directs delivery of a first shock between the electrically conductive case and at least one of the multiple cardiac electrodes in response to the first arrhythmic condition and directs delivery of a second shock between the electrically conductive case and at least one of the multiple cardiac electrodes in response to the second arrhythmic condition, where the first shock and the second shock include at least one different electrical pathway.
17. The apparatus of claim 16, wherein the first arrhythmic condition is an atrial arrhythmia and the second arrhythmic condition is a ventricular arrhythmia.
18. The apparatus of claim 16, wherein the multiple cardiac electrodes include a first defibrillation electrode adapted to be positioned in a supraventricular region, and where the first shock is between at least the first defibrillation electrode and the electrically conductive case.
19. The apparatus of claim 18, wherein the first defibrillation electrode is adapted to be positioned in or near an atrium of the supraventricular region.
20. The apparatus of claim 4, wherein the multiple cardiac electrodes include a second defibrillation electrode adapted to be positioned in a right ventricle, and where the second shock is at least between the second defibrillation electrode and the pulse generator housing.
21. The apparatus of claim 20, wherein the multiple cardiac electrodes include a third defibrillation electrode adapted to be positioned at least partially in a superior vena cava, and where the second shock is at least between the second defibrillation electrode, the third defibrillation electrode and the pulse generator housing, the third defibrillation electrode and the pulse generator housing being common.
22. An apparatus, comprising:
means for sensing cardiac signals;
means for detecting a first cardiac condition from one or more of the cardiac signals;
means for applying a first shock in response to the first cardiac condition, the first shock having a first shock vector between a pulse generator housing and at least one of a multiple of electrodes;
means for detecting a second cardiac condition from one or more of the cardiac signals; and
means for applying a second shock in response to the second cardiac condition, the second shock having a second shock vector, different than the first shock vector, between the pulse generator housing and at least one of the multiple electrodes.
23. The method of claim 22, wherein the means for detecting the first cardiac condition includes means for detecting an atrial arrhythmia.
24. The method of claim 23, wherein the means for detecting the second cardiac condition includes means for detecting a ventricular arrhythmia.
25. The method of claim 24, where the means for applying the first shock with the first vector includes means for applying the first shock between a first defibrillation electrode in a supraventricular region and the pulse generator housing.
26. The method of claim 25, wherein the supraventricular region is in or near an atrium.
27. The method of claim 25, where the means for applying the second shock with the second vector includes means for applying the second shock between a second defibrillation electrode in a right ventricular region and the pulse generator housing.
28. The method of claim 27, where the means for applying the second shock with the second vector includes means for applying the second shock between the second defibrillation electrode, the third defibrillation electrode at least partially in a superior vena cava and the pulse generator housing, where the third defibrillation electrode and the pulse generator housing are common.
US09/689,018 1990-04-25 2000-10-12 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode Expired - Fee Related US6280462B1 (en)

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US09/689,018 US6280462B1 (en) 1990-04-25 2000-10-12 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US09/884,862 US6999814B2 (en) 1990-04-25 2001-06-19 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US11/026,707 US7522959B2 (en) 1990-04-25 2004-12-30 Subcutaneous cardiac rhythm management
US11/324,474 US20060142804A1 (en) 1990-04-25 2006-01-03 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode

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US07/514,251 US5133353A (en) 1990-04-25 1990-04-25 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US07/917,899 US5301503A (en) 1991-07-26 1992-07-24 Vehicle internal combustion engine exhaust system
US08/380,538 US5713926A (en) 1990-04-25 1995-01-30 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US08/964,120 US5916238A (en) 1990-04-25 1997-11-04 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US09/344,843 US6157860A (en) 1990-04-25 1999-06-28 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US09/689,018 US6280462B1 (en) 1990-04-25 2000-10-12 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode

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US09/884,862 Continuation US6999814B2 (en) 1990-04-25 2001-06-19 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode

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US08/380,538 Expired - Lifetime US5713926A (en) 1990-04-25 1995-01-30 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US08/964,120 Expired - Lifetime US5916238A (en) 1990-04-25 1997-11-04 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US09/344,843 Expired - Lifetime US6157860A (en) 1990-04-25 1999-06-28 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US09/689,018 Expired - Fee Related US6280462B1 (en) 1990-04-25 2000-10-12 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US09/884,862 Expired - Fee Related US6999814B2 (en) 1990-04-25 2001-06-19 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US11/026,707 Expired - Fee Related US7522959B2 (en) 1990-04-25 2004-12-30 Subcutaneous cardiac rhythm management
US11/324,474 Abandoned US20060142804A1 (en) 1990-04-25 2006-01-03 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode

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US08/964,120 Expired - Lifetime US5916238A (en) 1990-04-25 1997-11-04 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode
US09/344,843 Expired - Lifetime US6157860A (en) 1990-04-25 1999-06-28 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode

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US11/026,707 Expired - Fee Related US7522959B2 (en) 1990-04-25 2004-12-30 Subcutaneous cardiac rhythm management
US11/324,474 Abandoned US20060142804A1 (en) 1990-04-25 2006-01-03 Implantable intravenous cardiac stimulation system with pulse generator housing serving as optional additional electrode

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US5713926A (en) 1998-02-03
US6157860A (en) 2000-12-05
US20020091418A1 (en) 2002-07-11
US5916238A (en) 1999-06-29
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US20050119707A1 (en) 2005-06-02
US20060142804A1 (en) 2006-06-29

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